The following data is part of a premarket notification filed by Depuy Mitek Inc., A Johnson And Johnson Company with the FDA for Orthocord.
Device ID | K123668 |
510k Number | K123668 |
Device Name: | ORTHOCORD |
Classification | Suture, Surgical, Absorbable, Polydioxanone |
Applicant | DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
Contact | Tatyana Korsunsky |
Correspondent | Tatyana Korsunsky DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
Product Code | NEW |
CFR Regulation Number | 878.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-29 |
Decision Date | 2013-02-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20886705022967 | K123668 | 000 |
20886705022950 | K123668 | 000 |
20886705022943 | K123668 | 000 |
20886705022936 | K123668 | 000 |
20886705022929 | K123668 | 000 |
20886705022912 | K123668 | 000 |
20886705022905 | K123668 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORTHOCORD 78382222 3340861 Live/Registered |
Johnson & Johnson 2004-03-11 |